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FDA 510(k)

ENDO FMS UROLOGY

K-Number: K980808 · 1998-05-08

ApplicantFuture Medical Systems, Inc.
Decision Date1998-05-08
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO FMS UROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Future Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-05-08 under 510(k) number K980808. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO FMS UROLOGY?

ENDO FMS UROLOGY is a medical device that received FDA 510(k) clearance on 1998-05-08. The listed applicant is Future Medical Systems, Inc.. The 510(k) number is K980808.

When did ENDO FMS UROLOGY receive FDA 510(k) clearance?

ENDO FMS UROLOGY received FDA 510(k) clearance on 1998-05-08, under 510(k) number K980808.

Who is the listed applicant for ENDO FMS UROLOGY?

The FDA 510(k) record lists Future Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO FMS UROLOGY?

The FDA product code for ENDO FMS UROLOGY is LJH.

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Other records listing Future Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LJH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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